21 CFR Part 11 compliance – PDF & Key Things to Know
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SciNote is a trusted solution used by the researchers at the FDA. In this article we have listed critical details about 21 CFR Part 11 compliance.
Historically, companies maintained a paper trail of all their equipment, experiments and results in order to comply with cGMP (Current Good Manufacturing Practices) and cGLP (Current Good Laboratory Practices) regulations. Today, with increasing amount of automatization, digital records and computer managed equipment the volume of digital data created and transferred has rapidly surmounted what is still feasible to maintain in paper records. This situation calls for a radical switch from paper records to digital records.
If your lab needs to be 21 CFR part 11, GMP or GLP compliant, you should read our page dedicated to lab compliance.
In a regulated environment, all digital information is controlled by 21 CFR Part 11. This is a set of instructions and guidelines about the creation, authentication and maintenance of digital records.
Compliance is a complex and resource- consuming process, it’s not limited to just buying and installing a “21 CFR Part 11 compliant” software. The whole system needs to be verified and when all the pieces of the puzzle are linked together, the laboratory can say it is 21 CFR Part 11 compliant.
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SciNote supports electronic signatures, electronic witnessing, audit trails and more.
If your lab needs to comply with 21 CFR part 11, GLP or GMP requirements, this is the PDF for you.
In order to comply with 21 CFR Part 11, you must take into account 4 important things: